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IRCT20181104041551N3 IRCT 2020-09-16 Mazandaran University of Medical Sciences Effect of erythropoietin on level of consciousness of brain trauma patients admitted to intensive care unit Clinical trial to compare the effect of erythropoietin and normal saline on level of consciousness of brain trauma patients admitted to intensive care unit 2020-08-21 anticipated 68 Complete https://irct.ir/trial/50573 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control with 34 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process, Blinding description: The patient and the final evaluator (intensive care subspecialist) will be unaware of the allocation in the study groups. Because the drug and placebo are colorless and there is no difference in subcutaneous injection. Because the project assistant is in the process of assigning groups, the intensive care unit sub-specialist is unaware of patients assignment to each group. 3 Brain trauma patients admitted to the ICU. Intervention 1: Intervention group: The intervention group will receive 4000 units of subcutaneous erythropoietin made by Pooyesh Daroo Company with a volume of half a cc on days 1, 3 and 5. Intervention 2: Control group: The control group will receive half a cc of subcutaneous normal saline 0.9% on days 1, 3 and 5 . Yes - There is a plan to make this available What will be shared: All data can be shared When: Starting from April 2021 To whom: People working in academic institutions Conditions: Everyone Where to obtain: Email to f.heydari@mazums.ac.ir How to obtain: Send email Comments:
public Dr. Fatemeh Heydari
Imam Hospital, Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 5714854367 +98 11 3336 1701 f.heydari@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Fatemeh Heydari
Imam Hospital, Amir Mazandarani Blvd.
Sari Iran (Islamic Republic of) 5714854367 +98 11 3336 1701 f.heydari@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with brain trauma with moderate GCS (7-12) The first 24 hours after trauma Expected time for the duration of hospitalization, at least 48 hours no limit no limit Both History of deep vein thrombosis, pulmonary embolism or any thromboembolic event Erythropoietin treatment in the last 30 days Systolic blood pressure ≥160 History of heart failure History of cancer Neurosurgery elective surgery S06.3 Focal traumatic brain injury Treatment - Drugs Placebo Intervention group: The intervention group will receive 4000 units of subcutaneous erythropoietin made by Pooyesh Daroo Company with a volume of half a cc on days 1, 3 and 5 Control group: The control group will receive half a cc of subcutaneous normal saline 0.9% on days 1, 3 and 5 . Level of conciousness. Timepoint: Daily until 14 days. Method of measurement: Glasgow Coma Scale and SOFA four-point scale. Deep vein thrombosis. Timepoint: Daily. Method of measurement: Daily visit of the limbs. Mazandaran University of Medical Sciences Approved 2020-06-16 Research Ethics Committee, Imam Hospital of Sari, Mazandaran University of Medical Sciences Imam Hospital, Amir Mzandarani Blvd. Sari Mazandaran Iran (Islamic Republic of)